Coronary Artery DiseaseNCT05240768
Clinical Outcomes of Patients With Deferred Revascularization Based on FFR and iFR Negative Coronary Artery Lesions.
An observational study of Coronary Artery Disease, run by Aga Khan University Hospital, Pakistan at 1 site in Pakistan.
Trial summary
The objective is to assess long-term clinical outcomes of patients in whom intervention of coronary lesions was deferred due to negative fractional flow reserve (FFR) and negative Instantaneous wave-free ratio (iFR) in a real-world patient population and to identify factors associated with deferred target lesion… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Fractional flow reserve, instantaneous wave-free Ratio
- How many people
- 345 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jan 2020to 20 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Mean age of study population was 62 ±11 years and majority (71%) of the population was male.76% (263) of the population was hypertensive, diabetes mellitus and dyslipidemia was present in 49%(169) and 53%(185) respectively. History of myocardial infarction (MI) was present in 12% (43) and one-fourth of population had history of revascularization, i.e PCI (19%) or coronary artery bypass grafting(CABG) 3%.
Who may be able to join
- Patients who had intermediate to severe coronary lesions on coronary angiogram.
- Patients who had negative FFR >0.80 or iFR >0.89 and did not undergo immediate or planned revascularization on basis of negative physiologic assessment.
Who cannot join
- Patients younger than 18 years of age or those having positive FFR/iFR values irrespective of revascularization status were excluded.
- Similarly, those who were lost to follow up and could not be traced via telephonic or were also excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Outcomes of Patients With Deferred Revascularization Based on Fractional Flow Reserve (FFR) and Instantaneous Wave-free Ratio (iFR) Negative Coronary Artery Lesions in Pakistani Population
The objective is to assess long-term clinical outcomes of patients in whom intervention of coronary lesions was deferred due to negative fractional flow reserve (FFR) and negative Instantaneous wave-free ratio (iFR) in a real-world patient population and to identify factors associated with deferred target lesion failure.
Read the detailed description
Fractional flow Reserve (FFR) evaluates functional significance of stenosis in intermediate coronary lesions. Instantaneous wave-free ratio (iFR) is considered noninferior to FFR and does not require adenosine administration.
This study was done to assess long-term clinical outcomes and factors associated with target vessel revascularization (TVR) in patients with deferred revascularization based on negative FFR and iFR.
Retrospective analysis of medical records of 345 patients with deferred revascularization at a tertiary care hospital , from January 2012 to January 2020 will be done.
- Conditions
- Coronary Artery Disease
- Being tested
- Fractional flow reserve, instantaneous wave-free Ratio
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional flow reserve, instantaneous wave-free RatioDiagnostic test
Clinical outcomes observed for patients with moderate coronary lesions in whom coronary revascularization was deferred due to a negative physiologic study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac death
Number of participants who died due to sudden cardiac arrest, sudden death due to acute MI and death due to heart failure or cardiogenic shock
Measured: 29 months
Non-fatal myocardial infarction
Number of patients suffering from Myocardial infarction but did not die.
Measured: 29 months
Target vessel revascularization.
Repeat PCI or bypass graft placement for a stenosis in another part of the vessel treated at the index PCI
Measured: 29 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start10 Jan 2020
- Primary completion1 Jun 2021
- Study completion20 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University Hospital, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamshed Ali, Aga Khan University Hospital, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240768
- Sponsor's protocol ID
- 2020-3681-10742
- Status last verified
- Feb 2022
- First submitted
- 3 Nov 2021
- Last updated
- 15 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Patients With Deferred Revascularization Based on Fractional Flow Reserve (FFR) and Instantaneous Wave-free Ratio (iFR) Negative Coronary Artery Lesions in Pakistani Population
- ClinicalTrials.gov ID
- NCT05240768
- Acronym / sponsor ID
- 2020-3681-10742
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- Aga Khan University Hospital, PakistanUniversity, hospital or other
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 20 Aug 2021 (actual)
- First posted
- 15 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective is to assess long-term clinical outcomes of patients in whom intervention of coronary lesions was deferred due to negative fractional flow reserve (FFR) and negative Instantaneous wave-free ratio (iFR) in a real-world patient population and to identify factors associated with deferred target lesion failure.
Detailed description
Fractional flow Reserve (FFR) evaluates functional significance of stenosis in intermediate coronary lesions. Instantaneous wave-free ratio (iFR) is considered noninferior to FFR and does not require adenosine administration.
This study was done to assess long-term clinical outcomes and factors associated with target vessel revascularization (TVR) in patients with deferred revascularization based on negative FFR and iFR.
Retrospective analysis of medical records of 345 patients with deferred revascularization at a tertiary care hospital , from January 2012 to January 2020 will be done.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Mean age of study population was 62 ±11 years and majority (71%) of the population was male.76% (263) of the population was hypertensive, diabetes mellitus and dyslipidemia was present in 49%(169) and 53%(185) respectively. History of myocardial infarction (MI) was present in 12% (43) and one-fourth of population had history of revascularization, i.e PCI (19%) or coronary artery bypass grafting(CABG) 3%.
Key inclusion criteria (2 listed)
- Patients who had intermediate to severe coronary lesions on coronary angiogram.
- Patients who had negative FFR >0.80 or iFR >0.89 and did not undergo immediate or planned revascularization on basis of negative physiologic assessment.
Key exclusion criteria (2 listed)
- Patients younger than 18 years of age or those having positive FFR/iFR values irrespective of revascularization status were excluded.
- Similarly, those who were lost to follow up and could not be traced via telephonic or were also excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fractional flow reserve, instantaneous wave-free RatioClinical outcomes observed for patients with moderate coronary lesions in whom coronary revascularization was deferred due to a negative physiologic study. | Diagnostic test | – |
Primary outcome
Cardiac death
Time frame: 29 months
Number of participants who died due to sudden cardiac arrest, sudden death due to acute MI and death due to heart failure or cardiogenic shock
Non-fatal myocardial infarction
Time frame: 29 months
Number of patients suffering from Myocardial infarction but did not die.
Target vessel revascularization.
Time frame: 29 months
Repeat PCI or bypass graft placement for a stenosis in another part of the vessel treated at the index PCI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Aga Khan University Hospital, Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac death (time frame: 29 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.